Class: Biological Therapy
Generic Name: nivolumab
Trade Name: Opdivo®
For which conditions is Opdivo approved for? Opdivo is approved to treat:
· Patients with melanoma that can’t be removed by surgery as a single agent or in combination with Yervoy® (ipilimumab)
· Patients with surgically removed melanoma involving the lymph nodes or metastatic disease in the adjuvant setting
Non-Small Cell Lung Cancer (NSCLC)
· Patients with metastatic NSCL expressing PD-L1 as first-line treatment in combination with Yervoy. PD-L1 expressing must be determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
· Patients with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations as first-line treatment in combination with Yervoy and 2 cycles of platinum-based chemotherapy.
· Patients with metastatic NSCL who have progressed on or after treatment with platinum-based chemotherapy. Patients with EGFR or ALK positive NSCLC should have progressed on an FDA-approved treatment for EGFR or ALK positive NSCL prior to receiving OPDIVO.
Gastric, Esophageal and GEJ Cancers
In combination with chemotherapy as initial treatment for individuals with advanced gastric, esophageal or GEJ cancers.
Small Cell Lung Cancer
· Patients with metastatic SCLC who have progressed after two treatments including platinum-based chemotherapy.
Renal Cell Carcinoma (RCC)
· Patients with advanced RCC who have had prior treatment with an anti-angiogenic therapy
· Patients with intermediate or poor risk, previously untreated advanced RCC in combination with Yervoy
Classical Hodgkin Lymphoma (cHL)
· Patients with cHL that has progressed following a hematopoietic stem cell transplant (HSCT) which has been followed by the chemotherapy/biologic drug Adcetris® or following 3 or more lines of systemic therapy that includes autologous HSCT.
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
· Patients with recurrent or metastatic SCCHN that has progressed on or after a platinum-based treatment.
· Patients with urothelial cancer that has advanced during or after treatment with a platinum-based chemotherapy or has advanced within 12 months of adjuvant or neoadjuvant treatment with a platinum-based chemotherapy.
· In combination with Yervoy or as a single agent in patients 12 years of age and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment.
Hepatocellular Carcinoma (HCC)
· In combination with Yervoy or as a single agent in patients with HCC who have previously received sorafenib.
Esophageal Squamous Cell Carcinoma (ESCC)
· Patients with advanced, recurrent or metastatic ESCC that cannot be treated with surgery who have received prior treatments. This indication is approved under accelerated approval and continued approval may be contingent upon verification of efficacy in additional studies.
What is the mechanism of action? Opdivo works by blocking the action of a protein called PD-1. Because PD-1 inhibits certain types of immune responses, drugs that block it may enhance the ability of the immune system to fight cancer.
How isOpdivo typically given (administered)? Opdivo is given as an intravenous infusion. The schedule and dose of Opdivo varies by approved indication.
How are patients typically monitored? Opdivo is designed to work with your immune system to attack cancer, but it can also cause your immune system to attack normal organs and tissues. Your doctor will monitor you (using blood tests and exams) for these complications: lung, intestinal, liver, kidney, and thyroid problems.
What are the most common side effects of treatment with Opdivo?
As a single agent:
- Muscle, joint, and bone pain
- Itchy skin
- Shortness of breath
- Decreased appetite
- Upper respiratory tract infection
- Abdominal pain
In combination with Yervoy:
· Itchy skin
· Muscle, join and bone pain
· Decreased appetite
· Abdominal pain
· Shortness of breath
· Upper respiratory tract infection
· Decreased Weight
In combination with Yervoy and platinum-doublet chemotherapy:
· Muscle, join and bone pain
· Decreased appetite
· Itchy skin
What are the less common but serious side effects of treatment with Opdivo?
- Lung problems (pneumonitis)
- Intestinal problems (colitis)
- Liver problems (hepatitis)
- Hormone gland problems
- Kidney problems
- Skin problems
- Inflammation of the brain (encephalitis)
- Problems in other organs
- Severe infusion reactions
- Complications of stem cell transplant that uses donor stem cells
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
- Keep your scheduled appointments for blood work or other laboratory tests that are used to monitor your health during treatment.
Are there any special precautions patients should be aware of before starting treatment?
Tell your doctor about all of your medical conditions, particularly the following:
- Immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
- If you’ve had an organ transplant
- Lung or breathing problems
- Liver problems
- Tell your doctor if you are pregnant or plan to become pregnant. Opdivo can harm your unborn baby, so you should not become pregnant during treatment with Opdivo. If you become pregnant during treatment or think you may be pregnant, tell your healthcare provider right away.
- Women who are able to become pregnant should use effective birth control during treatment with Opdivo and for one month after the last dose.
- Men who are sexually active should use a condom during treatment with Opdivo and for three months after the last dose.
- Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Opdivo will pass into your breast milk. You and your healthcare provider should decide if you will take Opdivo or breastfeed—you should not do both.
- Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of the medicines you take and show them to your healthcare providers and pharmacist when you get a new medicine.
When should patients notify their physician? Contact your doctor if you experience any of the following:
- Signs of lung problems (new or worsening cough; chest pain; shortness of breath)
- Signs of intestinal problems (diarrhea or more bowel movements than usual; blood in your stools or dark, tarry, sticky stools; severe stomach pain or tenderness)
- Signs of liver problems (yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach-area; drowsiness; dark urine; bleeding or bruise more easily than normal; feeling less hungry than usual)
- Signs of kidney problems (decrease in the amount of urine; blood in your urine; swelling in your ankles; loss of appetite)
- Signs of hormone gland problems (headaches that will not go away or unusual headaches; weight gain or weight loss; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness; hair loss; dizziness or fainting; feeling cold; constipation; deepening voice)
- Signs of other problems, including: rash, changes in eyesight, severe or persistent muscle or joint pains; severe muscle weakness
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.
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